Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery

Not Applicable

Completed

• Conditions: Thyroid Disease; Parathyroid Diseases; Primary Hyperparathyroidism; Parathyroid Adenoma

• Registration Number: NCT04344886
• Lead Sponsor: University Hospital Ostrava

Brief Summary

The radio-guided technique offers both help with in-vivo identification and ex-vivo confirmation of parathyroid adenoma. In-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.

Detailed Description

Despite the relatively accurate preoperative topographic information, minimally invasive parathyroid surgery can still be very challenging, especially in the case of small adenoma in ectopic localization. Radioguided technique offers both help with in-vivo identification and ex-vivo confirmation of adenoma. Excellent ex-vivo radio guidance results are referred. But, in-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-14
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult patients
• No history of thyroid or parathyroid surgery
• Diagnosis of primary hyperparathyroidism
• Indication for 99mTc-MIBI SPECT/CT examination

Exclusion Criteria

• Minor patients
• Negative SPECT/CT findings
• Patients refusing surgery
• Previous combined surgery on the thyroid gland
• Patients in high risk of general anesthesia
• Patients who do not undergo surgery in the recommended time span

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
In-vivo sensitivity (%)	3 months	Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background.
Ex-vivo sensitivity (%)	3 months	Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure.
Ex-vivo specificity (%)	3 months	Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure.
Ex-vivo accuracy (%)	3 months	Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure.
Success of surgery (%)	3 months	Surgery was considered successful if there were lowering of parathyroid hormone serum level and calcemia to normal and histological confirmation of parathyroid gland adenoma/ hyperplasia.
In-vivo specificity (%)	3 months	Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background.
In-vivo accuracy (%)	3 months	Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background.

Secondary Outcome Measures

Name	Time	Method
Pathological parathyroid gland localisation (ectopic x eutopic)	Duration of surgery	The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded.
Operating time (minutes)	Duration of surgery	The operating time will be measured and recorded.
Pathological parathyroid gland volume (ml)	Duration of surgery	The pathological parathyroid gland volume in millilitres will be measured and recorded.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia